
Vertex Pharmaceuticals
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Vertex Pharmaceuticals is a global biotechnology company dedicated to commercializing breakthrough drugs and improving the lives of people with serious diseases
74 Jobs
Financial Planning and Analysis Associate Director
Vertex PharmaceuticalsVertex Pharmaceuticals is a global biotechnology company dedicated to commercializing breakthrough drugs and improving the lives of people with serious diseases
Title: Financial Planning & Analysis Associate Director Location: Boston, MA, USA Job Description: Job Description Full time job requisition id REQ-29561 Job Description General Summary: The Associate Director, FP&A is a leader in Vertex's finance business partnering organization, providing financial direction and strategic insight to the key functional leaders. This role will help define and deliver against short term and long term goals, including identification of key value drivers and Business KPIs and provide strategic decision support, influencing decisions and identifying opportunities to invest, save costs and mitigate risks on a global basis. Key Duties and Responsibilities: - Provides financial direction and strategic insight to the functional leaders. Helps to define and deliver against short term and long term goals, including identification of key value drivers and Business KPIs. - Provides strategic decision support, influencing decisions and identifying opportunities to invest, save costs and mitigate risks on a global basis. - Leads a team of Business Partners ensuring coherent financial analysis and alignment across functions - responsibilities also include staff training and development, defining and evolving roles and responsibilities to meet business needs. - Leads the financial planning process for areas of responsibility (budget, forecast, long range plan) to provide meaningful forward looking direction, to develop key scenarios, and to identify key risks/uncertainties and plans for potential mitigation. - Leads the financial performance management process for areas of responsibility (objective setting, budget vs. actuals, etc), including the monthly forecast process, with a focus on understanding the key drivers of short term performance and communicating the range of possible outcomes. - Partners within FP&A and with accounting, GIS, HR and other functions to ensure there is clear ownership and management of the deliverables from those teams and that Finance services are delivered seamlessly to the business. - Ensures the financial integrity and robust corporate governance and compliance of all financial aspects for areas of responsibility. Knowledge and Skills: - Experience in pharmaceutical industry, business partnering with an executive team. - Strong skills demonstrated in MS Office and financial software applications, including Hyperion. - Strong communication, influencing and interpersonal skills necessary for daily interaction with senior management, as well as business partners and peers within Finance. - Ability to lead and drive change in a developing business environment, coordinating processes involving large numbers of people, complex systems, and tight deadlines across multiple time zones. - Capability to pro-actively participate in managing within a cross-cultural matrix organization. - Strong analytical and financial skills to evaluate a broad range of financial questions—especially portfolio analysis, valuation, ROI/ROIC, and complex business questions. - Capacity to understand the pharmaceutical industry to address a broad range of challenges and business issues globally across all functions with the ability to make and facilitate quick decisions. - Proven leadership expertise to manage and develop a high performing group of business partners. Education and Experience: - Bachelors degree in Finance, Accounting or an equivalent qualification. - Typically requires 8 years experience in a finance managerial role demonstrating strong technical and analytical skills or the equivalent combination of education and experience. - A track record of success working in a team-based environment. #HYBRID #LI-MF1 Pay Range: $156,000 - $234,000 Disclosure Statement: The range provided is based on what we believe is a reasonable estimate for the base salary pay range for this job at the time of posting. This role is eligible for an annual bonus and annual equity awards. Some roles may also be eligible for overtime pay, in accordance with federal and state requirements. Actual base salary pay will be based on a number of factors, including skills, competencies, experience, and other job-related factors permitted by law. At Vertex, our Total Rewards offerings also include inclusive market-leading benefits to meet our employees wherever they are in their career, financial, family and wellbeing journey while providing flexibility and resources to support their growth and aspirations. From medical, dental and vision benefits to generous paid time off (including a week-long company shutdown in the Summer and the Winter), educational assistance programs including student loan repayment, a generous commuting subsidy, matching charitable donations, 401(k) and so much more. Flex Designation: Hybrid-Eligible Or On-Site Eligible Flex Eligibility Status: In this Hybrid-Eligible role, you can choose to be designated as: 1. Hybrid: work remotely up to two days per week; or select 2. On-Site: work five days per week on-site with ad hoc flexibility. Note: The Flex status for this position is subject to Vertex’s Policy on Flex @ Vertex Program and may be changed at any time. #LI-Hybrid Company Information Vertex is a global biotechnology company that invests in scientific innovation. Vertex is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person's race, color, sex, gender identity or expression, age, religion, national origin, ancestry, ethnicity, disability, veteran status, genetic information, sexual orientation, marital status, or any characteristic protected under applicable law.
Project Management & Strategic Operations Director
Vertex PharmaceuticalsVertex Pharmaceuticals is a global biotechnology company dedicated to commercializing breakthrough drugs and improving the lives of people with serious diseases
Title: Project Management & Strategic Operations Director Location: 5000 - Vertex US - Fan Pier Job Description: Job Description General Summary: The Project Management & Strategic Operations Director serves as the end-to-end program lead for large-scale strategic programs of high business value within Global Regulatory Affairs (GRA). Drives benefit achievement by leading program initiation, planning, solution design and build, and by measuring key performance indicators and solution adoption. Engages other colleagues/resources and assigns appropriate responsibilities to support achievement of program roadmap and project plan(s). Independently applies expert knowledge of advanced methodologies, selecting and applying high-level project management tools to conduct analyses, reporting and related activities for assigned projects. Contributes to the development of internal protocols and processes used to carry out program management work. Responsible for program management activities including contingency/dependency tracking, status reporting, issue/risk identification and tracking, scope management, estimation, and internal/external stakeholder management. Provides oversight to workstream/task leads within the program; resolves any escalated project risks, issues and dependencies. Manages the overall scope and timing of the program, ensuring on-time and within budget delivery. Key Duties and Responsibilities: - Oversees end-to-end program management activities for large-scale, strategic programs of high business value, with oversight for the full project lifecycle - Manages the progress and contributions of workstream leads or subordinate project managers to ensure all activities deliver expected value within committed timeframes and budget - Manages contingencies between multiples projects and monitors interdependencies and synergies where required - Builds and synthesizes highly-detailed project plans, budgeting & forecasting models or resource plans, requiring significant stakeholder management skills and interpretation of diverse and varied information - Develops statements of work, stakeholder management plans, guiding principles, project goals, risks, resource allocation, and roles and responsibilities for assigned projects - Manage post-acquisition integration efforts for GRA including operational alignment, technology consolidation, data/document transfer, and talent integration - Secures, leads, motivates and inspires the internal and external resources required to effectively deliver the program. Establishes the program’s governance (e.g., sponsors, approvers, stakeholders) - Participates in the evaluation, selection and management of external resources or vendors - Provides transparency in project progress and effectively anticipates and mitigates major risks across the project lifecycle - Proactively crafts feasible solutions to combat risks and issues. Exercises sound judgement balancing risks and making prompt decisions in ambiguous or difficult situations - Manages communication with management at a detailed functional level and discusses/resolves issues - Works with all required functions and groups to effectively plan and execute the program/project(s). May coordinate resources across organizational boundaries - Trains and coaches project teams in execution methodologies and promotes adoption of best practices - Develops tools and training methods to enable successful project management throughout the enterprise. Ensures project delivery is in conformance with company methodologies and standards; recommends improvements and changes as necessary - Evaluates program costs and benefits including actual results and forecasts with comparisons to original or baseline plan and updates plans with accurate, up-to-date information in a timely manner. Reports financial information and status to leadership. Ensures program solution(s) meets quality and reliability requirements and that the launch approach meets or exceeds adoption targets. Monitors program results/performance for significant deviations, evaluates options and makes recommendations for corrective actions, and then implements selected actions Knowledge and Skills: - Proven experience in cross-functional execution including medium to large-scale projects - Critical thought partner and proven ability to connect people and ideas to drive outcomes - Demonstrated ability to connect with over divisions and functions throughout Vertex - Demonstrates the ability to effectively adopt and leverage emerging technologies, including AI driven tools, and maintains a continuous learning mindset - Ability to manage multiple priorities/projects at a given time, ensuring deadlines, budgets and status updates - Highly developed communication skills and the ability to synthesize data and information into meaningful insights - Very detail oriented and strong project/operation management skills - Ability to handle ambiguity Education and Experience: - Bachelor's degree - Typically requires 10 years of experience or the equivalent combination of education and experience *LI-EE1 Pay Range: $185,400 - $278,200 Disclosure Statement: The range provided is based on what we believe is a reasonable estimate for the base salary pay range for this job at the time of posting. This role is eligible for an annual bonus and annual equity awards. Some roles may also be eligible for overtime pay, in accordance with federal and state requirements. Actual base salary pay will be based on a number of factors, including skills, competencies, experience, and other job-related factors permitted by law. At Vertex, our Total Rewards offerings also include inclusive market-leading benefits to meet our employees wherever they are in their career, financial, family and wellbeing journey while providing flexibility and resources to support their growth and aspirations. From medical, dental and vision benefits to generous paid time off (including a week-long company shutdown in the Summer and the Winter), educational assistance programs including student loan repayment, a generous commuting subsidy, matching charitable donations, 401(k) and so much more. Flex Designation: Hybrid-Eligible Or On-Site Eligible Flex Eligibility Status: In this Hybrid-Eligible role, you can choose to be designated as: 1. Hybrid: work remotely up to two days per week; or select 2. On-Site: work five days per week on-site with ad hoc flexibility. Note: The Flex status for this position is subject to Vertex’s Policy on Flex @ Vertex Program and may be changed at any time. #LI-Hybrid Company Information Vertex is a global biotechnology company that invests in scientific innovation. Vertex is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person's race, color, sex, gender identity or expression, age, religion, national origin, ancestry, ethnicity, disability, veteran status, genetic information, sexual orientation, marital status, or any characteristic protected under applicable law. Vertex is an E-Verify Employer in the United States. Vertex will make reasonable accommodations for qualified individuals with known disabilities, in accordance with applicable law. Any applicant requiring an accommodation in connection with the hiring process and/or to perform the essential functions of the position for which the applicant has applied should make a request to the recruiter or hiring manager, or contact Talent Acquisition at ApplicationAssistance@vrtx.com
Principal Engineer, AI Authoring
Vertex PharmaceuticalsVertex Pharmaceuticals is a global biotechnology company dedicated to commercializing breakthrough drugs and improving the lives of people with serious diseases
Principal Engineer, Artificial Intelligence Authoring Location Boston, Massachusetts Employment Type Full-time Work Arrangement Hybrid (Hybrid-Eligible or On-Site Eligible) - Hybrid: Work remotely up to 2 days per week OR - On-Site: Work 5 days per week on-site Salary $166,640–$250,000 annually Job Description: Position Summary: We are seeking a highly skilled and visionary Principal Engineer, AI Authoring to join our AI Authoring Platform team. Reporting to the Director of AI Authoring Platform, you will lead the design, development, and optimization of Vertex’s AI-driven content generation engine. This role is pivotal in shaping the technical architecture of our platform, ensuring the performance, accuracy, and scalability of our LLM-powered authoring tools. You will tackle complex engineering challenges, including automated document workflows and Retrieval-Augmented Generation (RAG)-based architectures, to support the creation of high-quality, compliant, and efficient regulatory documents. Key Duties and Responsibilities - Design and maintain the end-to-end technical architecture for AI-assisted document generation, focusing on modular LLM integration, prompt engineering, and retrieval pipelines, while partnering closely with the AI Architect to ensure alignment with enterprise standards and scalability. - Build and optimize sophisticated Retrieval-Augmented Generation (RAG) systems that accurately pull from vast clinical and regulatory data sources to assist in document creation. - Engineer the data connectors and transformations required to feed structured and unstructured data into AI models for automated document population. - Develop and implement automated testing and validation frameworks to ensure AI-authored outputs meet the strict safety and compliance standards of the Life Sciences industry. - Rapidly prototype new AI authoring features, such as automated summarization or cross-document consistency checks, to determine technical viability before full-scale development. - Serve as the final escalation point for complex technical blockers, from debugging model hallucinations to optimizing cloud infrastructure for high-compute AI workloads. Knowledge and Skills - Proven experience in designing and implementing AI-driven platforms, particularly those leveraging LLMs and RAG architectures. - Expertise in prompt engineering, retrieval pipelines, and modular AI system design. - Strong background in engineering data workflows, including structured and unstructured data integration. - Experience with automated testing and validation frameworks, particularly in regulated industries. - Proficiency in cloud infrastructure optimization for AI workloads. - Exceptional problem-solving skills, with the ability to address complex technical challenges. - Strong collaboration and communication skills to work effectively with cross-functional teams - Familiarity with the Life Sciences industry and its compliance requirements (preferred). - Experience with automated document workflows and AI-based content generation (preferred). Education and Experience - 8+ years of experience in software engineering, with a focus on AI, machine learning, or technical platform development. - Proven track record of leading the design and implementation of AI-driven systems, including LLM-based platforms and RAG architectures. - Bachelor’s or Master’s degree in Computer Science, Artificial Intelligence, Data Science, or a related technical field. - Hands-on experience with cloud platforms (e.g., AWS, Azure, or GCP) and distributed computing systems. - Demonstrated expertise in building and deploying production-grade AI/ML systems in complex, data-intensive environments. - Experience working in regulated industries, such as Life Sciences, is a strong plus. Why Join Us? At Vertex, you will have the opportunity to work on cutting-edge technologies that make a real difference in people’s lives. We offer a collaborative and innovative work environment, competitive compensation, and opportunities for professional growth. If you are passionate about leveraging AI to revolutionize content generation and thrive in solving complex engineering challenges, we encourage you to apply and join our mission to transform lives through innovation. #LI-HYBRID Pay Range: $166,640 - $250,000 Disclosure Statement: The range provided is based on what we believe is a reasonable estimate for the base salary pay range for this job at the time of posting. This role is eligible for an annual bonus and annual equity awards. Some roles may also be eligible for overtime pay, in accordance with federal and state requirements. Actual base salary pay will be based on a number of factors, including skills, competencies, experience, and other job-related factors permitted by law. At Vertex, our Total Rewards offerings also include inclusive market-leading benefits to meet our employees wherever they are in their career, financial, family and wellbeing journey while providing flexibility and resources to support their growth and aspirations. From medical, dental and vision benefits to generous paid time off (including a week-long company shutdown in the Summer and the Winter), educational assistance programs including student loan repayment, a generous commuting subsidy, matching charitable donations, 401(k) and so much more. Flex Designation: Hybrid-Eligible Or On-Site Eligible Flex Eligibility Status: In this Hybrid-Eligible role, you can choose to be designated as: 1. Hybrid: work remotely up to two days per week; or select 2. On-Site: work five days per week on-site with ad hoc flexibility. Note: The Flex status for this position is subject to Vertex’s Policy on Flex @ Vertex Program and may be changed at any time. #LI-Hybrid Company Information Vertex is a global biotechnology company that invests in scientific innovation. Vertex is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person's race, color, sex, gender identity or expression, age, religion, national origin, ancestry, ethnicity, disability, veteran status, genetic information, sexual orientation, marital status, or any characteristic protected under applicable law. Vertex is an E-Verify Employer in the United States. Vertex will make reasonable accommodations for qualified individuals with known disabilities, in accordance with applicable law. Any applicant requiring an accommodation in connection with the hiring process and/or to perform the essential functions of the position for which the applicant has applied should make a request to the recruiter or hiring manager, or contact Talent Acquisition at ApplicationAssistance@vrtx.com
Associate Director, Contracting
Vertex PharmaceuticalsVertex Pharmaceuticals is a global biotechnology company dedicated to commercializing breakthrough drugs and improving the lives of people with serious diseases
Title: Associate Director, Contracting Location: 5000 - Vertex US - Fan Pier Job Description: Job Description General Summary: The Managed Care Contracting Associate Director will provide leadership and management oversight of Market Access Contract processes by facilitating negotiation and administration of all Payer, Provider and Trade & Distribution contracts. This person will partner with, among others, Account Management, Finance, Government Pricing & Rebate Operations, GTN, Legal, Marketing and Payer Marketing to ensure appropriate identification and evaluation of contracting opportunities. These responsibilities will apply across all Vertex marketed product lines and pipeline products. Key Duties and Responsibilities: - Manage the end-to-end Payer contract development process, including working with cross-functional partners on pre-deal analytics, negotiations, and post-deal analytics as well as the logging, tracking, reporting and facilitation of contract opportunities through the governance, negotiation/redlining and legal review processes - Develop, maintain and improve strong internal processes and documentation working across the Finance, Legal and Market Access teams - Maintain calendar and matrix of bids/offers and coordinate communication of contract development and execution status - Facilitate the transition of executed contracts to the appropriate operational team for implementation and/or adjudication, including outlining key terms and providing detailed explanations, as necessary - Provide insights to the business that inform GTN forecasting, contracting, and pricing decisions and strategies, and general business planning - Strong cross functional collaboration in support of internal contract processing, review, and reporting - Assist Account Managers with ad-hoc analysis, business planning, and contract performance review - Use financial models to perform and verify calculations for business scenarios, as needed - Advise on strategic and operational issues and requirements related to contract administration including any matters relating to rebate analysis and payments, as well as resolution of disputes on rebate claims Knowledge and Skills: - Progressive business experience in finance, accounting, sales, government pricing, contracting, or other related area - Understanding of pharmaceutical pricing government programs and associated regulations and the ability to determine the impact of contracts on them - Highly analytical and detail oriented, with the ability to define problems, research proposed solutions, analyze the short- and long-term implications, propose and present the results to key stakeholders and implement solutions - Advanced Microsoft Excel, Word and PowerPoint skills - Superior organizational and project management skills as well as polished written and verbal communication skills - Excellent interpersonal skills, customer service commitment, and detail orientation with the ability to work across the organization and external subject matter experts - Be self-motivated, requiring minimal supervision, and able to contribute as a team player - Ability to multitask, shift gears and pivot when necessary, and be comfortable working under constant deadlines - Deep working knowledge of the pharmaceutical and managed care industry including market dynamics and the competitive landscape of formulary coverage, market share and profitability Education and Experience: - Bachelor’s Degree in a business discipline required - Typically requires 8 years minimum experience in payer contracting, contract administration and/or analytics experience in the Pharmaceutical, Life Science or related Industries or the equivalent combination of education and experience Pay Range: $0 - $0 Disclosure Statement: The range provided is based on what we believe is a reasonable estimate for the base salary pay range for this job at the time of posting. This role is eligible for an annual bonus and annual equity awards. Some roles may also be eligible for overtime pay, in accordance with federal and state requirements. Actual base salary pay will be based on a number of factors, including skills, competencies, experience, and other job-related factors permitted by law. At Vertex, our Total Rewards offerings also include inclusive market-leading benefits to meet our employees wherever they are in their career, financial, family and wellbeing journey while providing flexibility and resources to support their growth and aspirations. From medical, dental and vision benefits to generous paid time off (including a week-long company shutdown in the Summer and the Winter), educational assistance programs including student loan repayment, a generous commuting subsidy, matching charitable donations, 401(k) and so much more. Flex Designation: Hybrid-Eligible Or On-Site Eligible Flex Eligibility Status: In this Hybrid-Eligible role, you can choose to be designated as: 1. Hybrid: work remotely up to two days per week; or select 2. On-Site: work five days per week on-site with ad hoc flexibility. Note: The Flex status for this position is subject to Vertex’s Policy on Flex @ Vertex Program and may be changed at any time. #LI-Hybrid Company Information Vertex is a global biotechnology company that invests in scientific innovation. Vertex is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person's race, color, sex, gender identity or expression, age, religion, national origin, ancestry, ethnicity, disability, veteran status, genetic information, sexual orientation, marital status, or any characteristic protected under applicable law. Vertex is an E-Verify Employer in the United States. Vertex will make reasonable accommodations for qualified individuals with known disabilities, in accordance with applicable law. Any applicant requiring an accommodation in connection with the hiring process and/or to perform the essential functions of the position for which the applicant has applied should make a request to the recruiter or hiring manager, or contact Talent Acquisition at ApplicationAssistance@vrtx.com
Senior Specialist, Quality Audit & Inspection
Vertex PharmaceuticalsVertex Pharmaceuticals is a global biotechnology company dedicated to commercializing breakthrough drugs and improving the lives of people with serious diseases
• Provide operational, administrative, and process support to the Audit and Inspection Management team. • Collaborate with cross-functional and external stakeholders to facilitate audit planning. • Maintain audit-related records and documentation, and assist in ensuring timely progression and closure of audit deliverables. • Support the management and progression of audit and inspection observation and CAPA records within the applicable quality management system. • Lead coordination of recurring team meetings and prepare meeting agendas and supporting materials. • Maintain and organize team SharePoint sites, document repositories, folders, tools, templates, and reference materials.
Regulatory Publishing Manager
Vertex PharmaceuticalsVertex Pharmaceuticals is a global biotechnology company dedicated to commercializing breakthrough drugs and improving the lives of people with serious diseases
Role Description The Regulatory Publishing Manager supports document-level regulatory publishing activities within a global Veeva Vault Publishing environment. This role focuses on preparing submission-ready regulatory documents through advanced Microsoft Word formatting, dynamic linking within Veeva, and compliant PDF generation. This position works within submission documents to ensure technical accuracy, formatting quality, and alignment with global regulatory standards. The role partners closely with document authors and regulatory stakeholders to embed quality into source documents, reduce time-to-file, and improve document reusability. This is an evolving environment requiring a self-starter comfortable working with refining templates, checklists, and processes. - Format complex regulatory documents in Microsoft Word to meet submission-ready standards. - Apply structured formatting, hyperlinks, bookmarks, cross-references, and linking best practices. - Convert Word source files into compliant, high-quality PDFs. - Work within Veeva Vault Publishing to manage document workflows and dynamic linking functionality. - Support report-level publishing (e.g., clinical reports, protocols, periodic reports). - Ensure alignment with global regulatory publishing standards and eCTD requirements. - Partner with document authors and SMEs to build quality into Word source documents early. - Provide guidance on submission-ready formatting standards. - Support refinement of evolving submission checklists and templates. - Manage multiple concurrent document priorities independently. Qualifications - 5–7 years of global regulatory publishing experience. - Strong knowledge of eCTD structure and electronic submission requirements. - Experience with Veeva Vault Publishing (direct experience strongly preferred). - Advanced Microsoft Word formatting expertise. - Experience generating submission-ready PDFs. - Ability to work independently in a developing, non–cookie-cutter environment. - Strong attention to detail and quality mindset. - Effective cross-functional communication skills. Requirements - Bachelor’s degree preferred but not required. - Experience supporting global regulatory submissions required. - Experience working in a system transition or evolving publishing environment preferred. Benefits - Contract Length: Through the end of the year, with the chance to extend. - Pay Range: $65/hr. - $75/hr. - Shift/Hours: Monday - Friday. Remote. EST hours.
Patient Safety Associate Medical Director
Vertex PharmaceuticalsVertex Pharmaceuticals is a global biotechnology company dedicated to commercializing breakthrough drugs and improving the lives of people with serious diseases
Title: Patient Safety Associate Medical Director Location: Boston, MA Job Description: Job Description General Summary: The Patient Safety Associate Medical Director will provide medical safety expertise, state of the art pharmacovigilance, and safety risk management for assigned products (marketed or in development). This role will optimizes patient safety of Vertex products and maintenance of compliance with the Pharmacovigilance regulations of Regulatory Agencies around the globe, through the effective and timely completion of Safety activities through the product life cycle. Key Duties and Responsibilities: - Provides medical safety expertise, state of the art pharmacovigilance, and safety risk management for assigned products (marketed or in development) - Responsible for the safety assessment activities of assigned products under the supervision of a GPS Disease-area Safety Head - Monitors the benefit risk profile of assigned products/portfolio in an ongoing fashion and in accordance GPS processes and procedures - Leads the safety and risk management processes including chairing assigned Disease-area Safety and Product Safety Teams - Identifies, prioritizes and analyzes clinical safety signals, in accordance with GPS procedures - Performs ongoing review of emerging safety data from various sources including single case reports, published literature, aggregate reports, and other sources - Represents the department as medical safety lead on cross-functional study and program teams for assigned products and studies, providing guidance regarding safety matters and issues - Conducts medical evaluation of relevant safety-related information from Toxicology, Non-Clinical studies, as well as Product Quality complaints, as needed - Participates in protocol development, specifically the monitoring and collection of safety information in clinical trial protocols, as well as statistical analysis plans - Participates in the analysis of safety data from on-going and completed clinical trials and representation in Clinical Study Reports - Contributes to preparation and review of periodic reports (DSUR, PSUR, PADER) contributing medical strategy and expertise to content, authoring applicable analysis and content - Review and provides medical content, as needed, for key study-related documents, e.g. IB, ICF, IDMC Charter - Assists in departmental development activities including SOP and Work Instructions development - Provides guidance to staff regarding optimal practice regarding collection, evaluation and processing of adverse experience reports, from a medical perspective - Provides support in Partner /Affiliate agreements and interactions, as needed - Other activities as needed or as requested by GPS management Knowledge and Skills: - Broad and extensive knowledge of medicine, pharmacovigilance and relevant regulations - Extensive evidence of effective delivery of high quality safety relevant documents. - Broad knowledge of relevant concepts in data management and systems, pharmacoepidemiology and statistics, including the interpretation of complex data and information - Communicates complex issues in an understandable, effective and relevant manner. - Strong influencing skills with the ability to explain and defend positions regarding significant issues in the face of opposition - Strategic focus regarding activities, with proactive planning and prioritization skills. - Takes ownership of appropriate issues and appropriately delegates - Technical expertise in pharmacovigilance and clinical safety - Excellent analytical and problem solving skills, with sound autonomy and applied judgment - Appropriate experience with Regulatory Agency and key stakeholder interactions - Experience with ICSR case review and Aggregate Safety analysis and reports Education and Experience: - MD, DO or equivalent ex-US medical degree - Typically requires 3 years of experience with relevant experience in Safety/Pharmacovigilance, or the equivalent combination of education and experience Pay Range: $200,000 - $300,000 Disclosure Statement: The range provided is based on what we believe is a reasonable estimate for the base salary pay range for this job at the time of posting. This role is eligible for an annual bonus and annual equity awards. Some roles may also be eligible for overtime pay, in accordance with federal and state requirements. Actual base salary pay will be based on a number of factors, including skills, competencies, experience, and other job-related factors permitted by law. At Vertex, our Total Rewards offerings also include inclusive market-leading benefits to meet our employees wherever they are in their career, financial, family and wellbeing journey while providing flexibility and resources to support their growth and aspirations. From medical, dental and vision benefits to generous paid time off (including a week-long company shutdown in the Summer and the Winter), educational assistance programs including student loan repayment, a generous commuting subsidy, matching charitable donations, 401(k) and so much more. Flex Designation: Hybrid-Eligible Or On-Site Eligible Flex Eligibility Status: In this Hybrid-Eligible role, you can choose to be designated as: 1. Hybrid: work remotely up to two days per week; or select 2. On-Site: work five days per week on-site with ad hoc flexibility. Note: The Flex status for this position is subject to Vertex’s Policy on Flex @ Vertex Program and may be changed at any time. #LI-Hybrid Company Information Vertex is a global biotechnology company that invests in scientific innovation. Vertex is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person's race, color, sex, gender identity or expression, age, religion, national origin, ancestry, ethnicity, disability, veteran status, genetic information, sexual orientation, marital status, or any characteristic protected under applicable law. Vertex is an E-Verify Employer in the United States. Vertex will make reasonable accommodations for qualified individuals with known disabilities, in accordance with applicable law. Any applicant requiring an accommodation in connection with the hiring process and/or to perform the essential functions of the position for which the applicant has applied should make a request to the recruiter or hiring manager, or contact Talent Acquisition at ApplicationAssistance@vrtx.com
R&D Quality Coordinator, Privacy & Risk Management
Vertex PharmaceuticalsVertex Pharmaceuticals is a global biotechnology company dedicated to commercializing breakthrough drugs and improving the lives of people with serious diseases
• Track and report GCP privacy events within RDQ in accordance with established procedures and workflows. • Manage a shared Privacy mailbox and related correspondence, ensuring timely tracking and follow up of related items. • Support Privacy Event Management, including initial assessments, guidance through resolution, and documentation to closure. • Analyze privacy risks and help implement appropriate mitigation strategies. • Provide documentation and coordination support to the RDQ Governance & Risk Management team. • Design, build, and maintain a centralized SharePoint site for the RDQ Governance & Risk Management team.
AD/Director – Organizational Change Management Lead – Quality Transformation Portfolio
Vertex PharmaceuticalsVertex Pharmaceuticals is a global biotechnology company dedicated to commercializing breakthrough drugs and improving the lives of people with serious diseases
• Develop and maintain an integrated OCM plan for Quality transformation programs. • Develop and maintain a portfolio-level view of OCM demand, priorities, risks, and resource needs across multiple Quality transformation initiatives. • Translate project scope, timeline, document changes, system releases, and process changes into a clear adoption roadmap. • Define OCM activities by change impact level: low, medium, high, and transformational. • Integrate OCM milestones into the broader project plan and phase gate process. • Identify adoption risks early and recommend mitigation actions. • Build stakeholder maps across Quality, Manufacturing, Labs, MSAT/ASAT, Regulatory, Technical Operations, Data, IT, Training, and external partner teams as applicable. • Conduct role-based change impact assessments. • Identify changes to responsibilities, decision rights, review behaviors, escalation paths, data usage, system interactions, and governance. • Group impacted populations by level of change and required OCM support. • Identify where new or updated SOPs/WIs require additional behavior change, training, communications, or manager reinforcement. • Support sponsors and senior leaders in articulating the case for change. • Develop sponsor talking points, leadership messages, and reinforcement actions. • Help leaders understand where visible sponsorship is required to reduce resistance and drive adoption. • Prepare leadership updates for program governance and Steering Committee forums. • Develop targeted communication plans for impacted stakeholder groups. • Create practical messaging that explains what is changing, why it matters, who is impacted, what actions are required, and when. • Support SME briefings, roadshows, office hours, FAQ development, manager toolkits, and readiness sessions. • Ensure communications are aligned with the project timeline, document effective dates, training deployment, and go-live waves. • Partner with Training, Quality Systems, process owners, and SMEs to ensure training is role-based and tied to actual future-state execution. • Identify where training alone is insufficient and where coaching, walkthroughs, job aids, or readiness checks are needed. • Support go-live readiness assessments across people, process, technology, data, documents, and support model. • Define readiness criteria for each go-live wave. • Define 30/60/90-day sustainment plans after go-live. • Establish adoption metrics, feedback loops, issue escalation paths, and business-as-usual ownership. • Monitor adoption risks, behavior drift, workarounds, and inconsistent execution. • Ensure lessons learned are captured and fed into future phases and programs.
Director, Digital Experiment Capture
Vertex PharmaceuticalsVertex Pharmaceuticals is a global biotechnology company dedicated to commercializing breakthrough drugs and improving the lives of people with serious diseases
Lead the strategy and operational delivery for ELN platforms, develop a team for platform support, and partner with scientists to ensure compliant and scalable solutions for experiment data capture across laboratory environments.
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